Actos (Pioglitazone)

Actos is the brand name for pioglitazone, a drug in the thiazolidinedione class that helps the body use insulin better. It has been used since 1999 to lower blood sugar in adults with type 2 diabetes, alone or in combination pills such as Actoplus Met and Duetact.

Its label carries several warnings, including a boxed warning about congestive heart failure. The one that drove litigation is bladder cancer. The current Actos prescribing information warns that the drug may increase the risk of bladder cancer, says it should not be used in patients with active bladder cancer, and advises caution in patients with a history of it. The FDA added bladder cancer information to the label in 2011 after reviewing interim results of a long-term study.

Thousands of patients who developed bladder cancer after taking Actos sued, claiming Takeda knew of the risk and did not warn doctors. After several large jury verdicts, Takeda agreed in 2015 to a settlement of about $2.4 billion to resolve the bulk of the pending cases, without admitting liability. That program has long since closed, and new claims today would face serious statute of limitations problems unless the diagnosis is recent and the person used the drug.

People still taking pioglitazone should report symptoms like blood in the urine, urgency, or pain when urinating to their doctor, and should not stop a diabetes drug without medical advice. For another diabetes drug case, see the metformin contamination lawsuit, and for how drug cases are organized, see what is MDL.